Vtama

(Tapinarof)

ApprovedSmall molecule

OOrganon and Co

Vtama is one of 48 small molecule programs targeting Atopic Dermatitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Atopic DermatitisNot yet recruiting

Palmoplantar KeratodermaActive, not recruiting

ICD10 Code L40.9 for PsoriasisEnrolling by invitation

Cutaneous Lupus ErythematosusEnrolling by invitation

Atopic DermatitisApproved

Not yet recruiting

Palmoplantar KeratodermaPhase 2

Active, not recruiting

ICD10 Code L40.9 for PsoriasisPreclinical

Enrolling by invitation

Cutaneous Lupus ErythematosusPhase 1

Enrolling by invitation

Competition

Competitive Landscape

116 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Vtama

OOrganon and Co

Approved

1 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

17 5

Amlitelimab

Sanofi

Phase 3

2 6

Certolizumab

Johnson & Johnson

Phase 3

1 7

DUPIXENT

Regeneron

Phase 3

1 8

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 9

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

5 10

MG-K10

SShanghai Mabgeek Biotech.Co.Ltd

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Active, not recruiting

Palmoplantar Keratoderma

NCT06561321

Q2 2030

Post-ApprovalNot yet recruiting

Atopic Dermatitis

NCT07352566

Clinical

Trials by Indication[1]

Psoriasis3 trials

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

Completed·OOrganon and Co·Phase 3·NCT03956355·510 enrolled

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

Completed·OOrganon and Co·Phase 3·NCT03983980·515 enrolled

Vtama in Psoriasis Patients Being Treated With Biologics.

Completed·PPsoriasis Treatment Center of Central New Jersey·Phase 4·NCT06103695·30 enrolled

Cutaneous Lupus Erythematosus1 trial

Tapinarof for Cutaneous Lupus Erythematosus

Enrolling by invitation·NNorthwestern University·Phase 1·NCT06661213·10 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

ICD10 Code L40.9 for Psoriasis1 trial

Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)

Enrolling by invitation·WWake Forest University Health Sciences·Preclinical·NCT05981118·40 enrolled

Palmoplantar Keratoderma1 trial

An Open-label, Phase II Study to Evaluate the Clinical Efficacy and Safety of Tapinarof for Adult Patients With Palmoplantar Keratoderma

Active, not recruiting·IIndiana University·Phase 2·NCT06561321·6 enrolled

Regulatory

FDA Approval Timeline[4]

May 23, 2022

VTAMA

NDA NDA215272

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Tapinarof. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tapinarof compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tapinarof. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215272). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vtama. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: OOrganon and Co

Patent Landscape[5]

Patent Cliff

May 19, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10195160May 19, 2036

11622945May 19, 2036

11458108May 19, 2036

10426743May 19, 2036

11612573May 19, 2036

7 more patents

11617724May 19, 2036

11597692Nov 13, 2038

10647649Nov 13, 2038

11590088Nov 13, 2039

11497718Nov 13, 2039

11938099Nov 13, 2039

12569453Dec 18, 2039

Vtama

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2030

Trials by Indication[1]

Psoriasis3 trials

Cutaneous Lupus Erythematosus1 trial

Atopic Dermatitis1 trial

ICD10 Code L40.9 for Psoriasis1 trial

Palmoplantar Keratoderma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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